Validation Engineer - Grand Haven Area

the-pivot-group-careers; Grand Haven (MI); On-site; USD 78,000 - 118,000; Full time

Job summary

The Pivot Group Network in Grand Haven, MI is seeking a Validation Engineer to develop and execute validation protocols for equipment, processes, and software. You will work with cross-functional teams to ensure compliance with cGMP and regulatory standards.

Candidates should have a bachelor's degree in engineering and 3+ years in validation within a regulated manufacturing environment, with strong knowledge of GxP, FDA regulations, and ISO 13485. Excellent technical writing is essential.

Qualifications

• Bachelor's degree in engineering or related field required.
• 3+ years of validation experience in regulated manufacturing (medical device/pharma).
• Strong knowledge of GxP, FDA regulations, and ISO 13485.

Responsibilities

• Develop, execute, and review validation protocols and reports for equipment, processes, and software.
• Perform risk assessments and generate validation master plans.
• Collaborate with cross-functional teams to align validation activities with timelines and regulatory requirements.
• Investigate and resolve deviations and non-conformances related to validation activities.
• Maintain and update validation documentation to ensure cGMP compliance.
• Participate in internal and external audits to present validation strategies and documentation.
• Provide technical expertise and training on validation principles and practices.

Skills

Validation protocols

IQ/OQ/PQ

Regulatory compliance

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in engineering

Job description

Validation Engineer | Grand Haven, MI

Salary Range: $78,000 - $118,000 depending on experience

Are you a dedicated professional with a passion for excelling in validation engineer? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is committed to fostering meaningful relationships and supporting career growth. We partner with leading manufacturing companies in Grand Haven, seeking experienced Validation Engineers to strengthen their teams.

We are building our network of talent in this field across West Michigan and the broader manufacturing region Pivot Group Network serves. Our partner companies may or may not have an immediate opening for this exact role today, but we actively look for skilled professionals in the regions where they operate. If there is alignment now or in the near future, we reach out.

The Opportunity

We are collaborating with manufacturing firms in Grand Haven that are seeking skilled Validation Engineers. These organizations are dedicated to maintaining high standards and are looking for professionals who can contribute effectively. By joining our network, you position yourself for opportunities aligned with your career goals.

Key Responsibilities

• Develop, execute, and review validation protocols and reports for equipment, processes, and software.
• Perform risk assessments and generate validation master plans.
• Collaborate with cross-functional teams to ensure validation activities align with project timelines and regulatory requirements.
• Investigate and resolve deviations and non-conformances related to validation activities.
• Maintain and update validation documentation to ensure compliance with cGMP and industry standards.
• Participate in internal and external audits to present validation strategies and documentation.
• Provide technical expertise and training on validation principles and practices.

Recommended Qualifications

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical device, pharmaceutical).
• Strong understanding of GxP, FDA regulations, and industry standards (e.g., ISO 13485).
• Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Excellent technical writing skills for authoring validation documentation.

Bonus Qualifications

• Additional certifications or training

Job Titles That Should Apply

Validation Engineer, Senior Validation Engineer, Principal Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Quality Engineer, QA Validation Engineer, Compliance Engineer, Validation Specialist, Validation Lead, Validation Manager